⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Regorafenib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Who Have Completed Chemoradiation Therapy and Surgery

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Regorafenib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Who Have Completed Chemoradiation Therapy and Surgery

Official Title: Randomized Phase II Double Blind Study of Adjuvant Regorafenib vs Placebo in Patients With Node Positive Esophageal Cancer That Completed Pre-operative Therapy

Study ID: NCT02234180

Interventions

Placebo
Regorafenib

Study Description

Brief Summary: This randomized phase II trial studies how well regorafenib works in treating patients with cancer of the esophagus or gastroesophageal junction that has spread from where it started to nearby tissue or lymph nodes and have completed chemoradiation therapy and surgery. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description: PRIMARY OBJECTIVES: I. To compare the disease-free survival (DFS) for patients with resected esophageal and gastroesophageal (GE) junction adenocarcinoma treated with regorafenib vs. placebo in the adjuvant setting. SECONDARY OBJECTIVES: I. To compare the safety profile of adjuvant regorafenib vs. placebo in patients with locally advanced resectable esophageal and GE junction adenocarcinoma. II. To compare the overall survival (OS) for patients with resected esophageal and GE junction adenocarcinoma treated with regorafenib vs. placebo in the adjuvant setting. III. To compare the DFS in those patients that receive at least 1 cycle of therapy. IV. To collect tumor samples for future genomic analysis to explore the biology of locally advanced esophageal and GE junction adenocarcinoma. V. DFS will be compared between the arms from the time of surgery as well. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Within 6-12 weeks after surgery, patients receive regorafenib orally (PO) once daily (QD) on days 1-21. ARM II: Within 6-12 weeks after surgery, patients receive placebo PO QD on days 1-21. In both arms, courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, and every 6 months for up to 5 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Carle Cancer Center, Urbana, Illinois, United States

Cancer Center of Kansas - Wichita, Wichita, Kansas, United States

Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States

Mayo Clinic, Rochester, Minnesota, United States

Missouri Valley Cancer Consortium, Omaha, Nebraska, United States

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States

Contact Details

Name: Yelena Janjigian

Affiliation: Academic and Community Cancer Research United

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: